QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS

Lamotrigine Assay

SERADYN INC.

The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Qms Lamotrigine Assay (reagents), Calibrators & Controls.

Pre-market Notification Details

Device IDK062966
510k NumberK062966
Device Name:QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
ClassificationLamotrigine Assay
Applicant SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
ContactJack Rogers
CorrespondentJack Rogers
SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
Product CodeORH  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-29
Decision Date2007-01-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883012684 K062966 000
00884883011274 K062966 000
00884883011267 K062966 000
00884883011168 K062966 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.